Phase 3Recruiting
Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal
- Sponsor
- Thomas Jefferson University (Academic or other)
- Enrolment
- 660 planned
- Conditions
- Liver Diseases; Portal Hypertension
- Interventions
- SHAPE measurement (Sonazoid ultrasoud contrast agent); SHAPE measurement (Definity ultrasoud contrast agent)
- Ages
- adults, older adults
- Registry
- NCT05470205
From the registry
This is an open-label, non-randomized trial that will be conducted at three clinical sites, Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts depending on the inclusion criteria for each cohort. Cohort 1: Patients scheduled for hepatic vein pressure gradient (HVPG) measurements will subsequently undergo two consecutive SHAPE (subharmonic aided pressure estimation) procedures using different ultrasound contrast agents (Definity \[Lantheus Medical Imaging, N Bilerica, MA, USA\] and Sonazoid \[GE Healthcare, Oslo, Norway\] in randomized order) to estimate portal pressures with a Logiq E10 scanner (GE Healthcare, Waukesha, WI, USA) and determine the reproducibility of the SHAPE algorithm. Cohort 2: Patients identified as having clinically significant portal hypertension (CSPH) will be monitored by SHAPE with Sonazoid for the duration of this project (18-24 months on average). These subjects will have follow-up ultrasound scans every 6 ± 2 months to check…
Primary outcomes
- Reproducibility of SHAPE liver pressure measurements
- Number of subjects who develop ascites during follow-up
- Number of subjects who experience clinical decompensation events (including the development of variceal bleeding) during follow-up
- Number of subjects who present with esophageal or gastric varices on endoscopy